Associate Director or Director, Late Stage CMC Lead - Cell Therapy

Company: Bristol Myers Squibb
Location: Seattle
Posted on: November 25, 2022

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. The Associate Director or Director, CMC Team Leader will lead the development of the CMC strategy for one or more programs and drive the development and execution of the CMC strategy with focus on late-stage assets within Cell Therapy Development & Operation (CTDO) organization. The individual will lead a cross functional CMC team across vector, drug product, analytical, quality, regulatory, supply chain, manufacturing operations and clinical supplies. CMC Team Lead is accountable for developing and delivering the Integrated CMC development plan and will work with cross-functional stakeholders to drive alignment and achievement of CMC development and manufacturing milestones in accordance with program timelines. As a member of the global Product Development Team (DPT), this role will ensure full alignment of the CMC and manufacturing plans with the clinical development, business and regulatory strategies and work with the Global Operation team (GO-CT) for commercial launch plans. In addition, the individual may also serve as project management interface between our internal functions, external business partners, and CDMO/CRO/CMO's project teams. Responsibilities Lead and represent the cross-functional CMC team with focus on late-stage programs through global commercial license application and approval Define and implement the Integrated CMC Product Development strategy for the programs and drive alignment with functional leaders across CTDO and other key stakeholders Work across functions to ensure development and manufacturing activities are delivered in accordance with DPT timelines and executed on time according to plan Align CMC team members and sub-teams across geographic locations on content and strategy and create synergy in activities taking place at multiple sites. This includes external/internal manufacturing campaigns, process/analytical development, functional characterization, release testing, tech. transfer, comparability campaigns, stability studies, regulatory filings, and other CMC-related activities. Lead the CMC Team to track, compile, review, and ensure timely delivery of documents in support of regulatory filings and responses. Ensure the proper scientific rigor to deliver successful clinical outcomes, meet registration needs. Lead the cross-functional joint project team in managing the technology transfer and development/manufacturing/testing/logistics CMC activities at the CDMO/CRO/CMO. Work with CMC project managers and functional leads to ensure appropriate resourcing and budget development by strategic assessment of milestones and corresponding resource requirements, while providing periodic review of forecasted expenditures. Regularly communicates cross functionally to assess and confirm appropriate allocation and utilization of resources. Provide guidance and mentorship to the functional leads/subject matter experts within the CMC team. Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives. Builds and motivates teams to become high performing. Actively involve and support the initiatives to support CTDO Pipeline and Product Lifecycle Strategy (PPLS) business operations, such as streamline development strategies across early to late stage projects, and establish knowledge management system. Requirements for Associate Director: BS/MS or PhD in a scientific field with =10 years of experience in product development Demonstrated ability for critical thinking and innovation; highly motivated, willingness to acquire new skills and ability to work under ambiguous environment In-depth technical understanding of drug development of gene or cell therapy products (preferred) or biologics, including Process/Analytical Development, and GMP Manufacturing, and CMC Regulatory. Demonstrated successful track record to work with matrix teams to successfully drive results. Proficiency in strategic planning, cross-functional performance management, people dynamic management, and technical leadership. Experienced with CMC Regulatory strategy to drive resolution of health authority questions or requests and the milestones and activities necessary to drive regulatory filing documentation. Proven leadership experience and savvy influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team-building, communication, and organizational skills required. Excellent written and verbal communication skills Requirements for Director: BS/MS or PhD in a scientific field with =12 years of experience in product development Demonstrated ability for critical thinking and innovation; highly motivated, willingness to acquire new skills and ability to work under ambiguous environment Demonstrated successful cross-functional leadership track record and ability to work with teams to successfully drive results. Proficiency in strategic planning, cross-functional performance management, people dynamic management, and technical leadership. In-depth technical understanding of early and late-stage clinical development of cell therapy products, including Process/Analytical Development, GMP Manufacturing CMC, and Regulatory. In-depth experience with CMC Regulatory strategy to drive resolution of health authority questions or requests and the milestones and activities necessary to drive regulatory filing documentation. Proven leadership experience and savvy influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team-building, communication, and organizational skills required. Excellent written and verbal communication skills If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupportbms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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